Chronic DiseasesNCT02351648
A Randomised Control Trial of a Transitional Care Model in Singapore General Hospital
A study testing a transitional care model in people with Chronic Diseases, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
To find out if a transitional care model can reduce the rate of unscheduled readmission to the Department of Internal Medicine (DIM) in SGH Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- a transitional care model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -More than 1 admission in the last 90 days
Who cannot join
- Subject is a non-resident
- Subject has no local home address
- Subject is from a long-term care facility during index admission
- Subject is unable to participate in telephone surveillance
- Subject is discharged before takeover
- Subject has impaired decision making capacity without surrogate decision maker
Show all 14Show fewer
- Subject is pending or currently in critical care unit
- Subject or caregiver is mentally unstable
- Subject is haemodynamically unstable
- Subject requires acute inpatient respiratory support
- Subject requires acute inpatient dialysis support
- Subject pending surgical intervention
- Subject pending transfer to other specialist discipline
- Primary team consultant declined to participate in this research
Trial locations and contacts
1 site in 1 country.
About this study
To find out if a transitional care model can reduce the rate of unscheduled readmission to the Department of Internal Medicine (DIM) in SGH
Read the detailed description
Hospital with high readmission rate is view as having lower quality of care High readmission rate is view as wasteful healthcare spending
Primary Aim:
To find out if a transitional care model can reduce the rate of unscheduled readmission to the Department of Internal Medicine (DIM) in SGH A readmission episode is defined as an episode of readmission to any tertiary hospital within 30 days after index discharge from SGH
Secondary Aim:
To find out if a transitional care model can reduce the number of visits to the emergency department in SGH To find out the quality of our transitional care model by using a care transition measure (CTM-15)
- Conditions
- Chronic Diseases
- Being tested
- a transitional care model, Control
- Keywords
- readmission, care transition
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a transitional care modelOther
Intervention extend from transfer of care to the study team from the initial admission medical team through 90 days after discharge
Intervention in hospital includes the following. Comprehensive discharge planning based on the 6 principles. Discharge planning initially within 24 hours of recruitment Daily ward review of patients Weekly multi-disciplinary meeting Consolidation of medication and follow-up appointment before discharge Assessment of needs before discharge Comprehensive discharge summary and medication record at discharge
Intervention after discharge:
Work done mainly by integrated care nurse Review of patients within 48 hours after discharge via home visit or phone call Subsequent home visit as needed based on patient's needs At least weekly contact with pt or caregiver via telephone Telephone availability working weekday 8 AM to 5 PM Multi-disciplinary meeting for problematic cases Use chronic disease pathway for suitable patients
ControlOther
Patients receive usual standard of care from the internal medicine team
| Study group | Role | What they receive |
|---|---|---|
| Intervention' | Experimental | Intervention extend from transfer of care to the study team from the initial admission medical team through 90 days after discharge
Intervention in hospital includes the following. Comprehensive discharge planning based on the 6 principles. Discharge planning initially within 24 hours of recruitment Daily ward review of patients Weekly multi-disciplinary meeting Consolidation of medication and follow-up appointment before discharge Assessment of needs before discharge Comprehensive discharge summary and medication record at discharge
Intervention after discharge:
Work done mainly by integrated care nurse Review of patients within 48 hours after discharge via home visit or phone call Subsequent home visit as needed based on patient's needs At least weekly contact with pt or caregiver via telephone Telephone availability working weekday 8 AM to 5 PM Multi-disciplinary meeting for problematic cases Use chronic disease pathway for suitable patients Receives: Other: a transitional care model |
| Control' | Active comparator | Patients receive usual standard of care from the internal medicine team Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission rate
A readmission episode is defined as an episode of readmission to any tertiary hospital within 30 days after index discharge from SGH Readmission rate is calculated by dividing the total number of admission by the total number of patients
Measured: 30 days after index discharge
Secondary outcomes (5)
Readmission rate
Readmission rate is calculated by dividing the total number of admission by the total number of patients. This will measured at 7 days, 90 days and 180 days of discharge
Measured: up to 180 days after index discharge
Quality of transitional care using a validated care transition measure (CTM-15) tool
Care transition measure survey of subjects
Measured: 90 days after index discharge
Emergency department attendance rate
Emergency department attendance rate is calculated by dividing the total number of emergency department visits by the total number of patients. This will measured at 7 days, 30 days, 90 days and 180 days of discharge
Measured: Up to 180 days after index discharge
Time to first readmission
Censored time to readmission for both intervention and control group
Measured: Up to 90 days after index discharge
Specialist Outpatient Clinic visits
Outpatient clinic visit rate is calculated by dividing the total number of outpatient clinic visits by the total number of patients. This will measured at 90 days and 180 days of discharge
Measured: Up to 180 days after index discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Integrated Care, Singapore, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Kheng Hock Lee, MBBS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351648
- Sponsor's protocol ID
- 2012/848/E
- Status last verified
- Jan 2015
- First submitted
- 21 Jan 2015
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Coleman EA, Smith JD, Frank JC, Eilertsen TB, Thiare JN, Kramer AM. Development and testing of a measure designed to assess the quality of care transitions. Int J Integr Care. 2002;2:e02. doi: 10.5334/ijic.60. Epub 2002 Jun 1.
PubMed 16896392Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
PubMed 12558354Mistiaen P, Poot E. Telephone follow-up, initiated by a hospital-based health professional, for postdischarge problems in patients discharged from hospital to home. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD004510. doi: 10.1002/14651858.CD004510.pub3.
PubMed 17054207
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of a Transitional Care Model in Singapore General Hospital
- ClinicalTrials.gov ID
- NCT02351648
- Acronym / sponsor ID
- 2012/848/E
- Conditions
- Chronic Diseases
- Keywords
- readmission, care transition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Agency for Integrated Care, Singapore, Duke-NUS Graduate Medical School
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find out if a transitional care model can reduce the rate of unscheduled readmission to the Department of Internal Medicine (DIM) in SGH
Detailed description
Hospital with high readmission rate is view as having lower quality of care High readmission rate is view as wasteful healthcare spending
Primary Aim:
To find out if a transitional care model can reduce the rate of unscheduled readmission to the Department of Internal Medicine (DIM) in SGH A readmission episode is defined as an episode of readmission to any tertiary hospital within 30 days after index discharge from SGH
Secondary Aim:
To find out if a transitional care model can reduce the number of visits to the emergency department in SGH To find out the quality of our transitional care model by using a care transition measure (CTM-15)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention' | Experimental | Other: a transitional care modelIntervention extend from transfer of care to the study team from the initial admission medical team through 90 days after discharge Intervention in hospital includes the following. Comprehensive discharge planning based on the 6 principles. Discharge planning initially within 24 hours of recruitment Daily ward review of patients Weekly multi-disciplinary meeting Consolidation of medication and follow-up appointment before discharge Assessment of needs before discharge Comprehensive discharge summary and medication record at discharge Intervention after discharge: Work done mainly by integrated care nurse Review of patients within 48 hours after discharge via home visit or phone call Subsequent home visit as needed based on patient's needs At least weekly contact with pt or caregiver via telephone Telephone availability working weekday 8 AM to 5 PM Multi-disciplinary meeting for problematic cases Use chronic disease pathway for suitable patients |
| Control' | Active comparator | Other: ControlPatients receive usual standard of care from the internal medicine team |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -More than 1 admission in the last 90 days
Key exclusion criteria (14 listed)
- Subject is a non-resident
- Subject has no local home address
- Subject is from a long-term care facility during index admission
- Subject is unable to participate in telephone surveillance
- Subject is discharged before takeover
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a transitional care modelIntervention extend from transfer of care to the study team from the initial admission medical team through 90 days after discharge Intervention in hospital includes the following. Comprehensive discharge planning based on the 6 principles. Discharge planning initially within 24 hours of recruitment Daily ward review of patients Weekly multi-disciplinary meeting Consolidation of medication and follow-up appointment before discharge Assessment of needs before discharge Comprehensive discharge summary and medication record at discharge Intervention after discharge: Work done mainly by integrated care nurse Review of patients within 48 hours after discharge via home visit or phone call Subsequent home visit as needed based on patient's needs At least weekly contact with pt or caregiver via telephone Telephone availability working weekday 8 AM to 5 PM Multi-disciplinary meeting for problematic cases Use chronic disease pathway for suitable patients | Other | Intervention' |
| ControlPatients receive usual standard of care from the internal medicine team | Other | Control' |
Primary outcome
Readmission rate
Time frame: 30 days after index discharge
A readmission episode is defined as an episode of readmission to any tertiary hospital within 30 days after index discharge from SGH Readmission rate is calculated by dividing the total number of admission by the total number of patients
5 secondary outcomes
Readmission rate
Time frame: up to 180 days after index discharge
Quality of transitional care using a validated care transition measure (CTM-15) tool
Time frame: 90 days after index discharge
Emergency department attendance rate
Time frame: Up to 180 days after index discharge
Time to first readmission
Time frame: Up to 90 days after index discharge
Specialist Outpatient Clinic visits
Time frame: Up to 180 days after index discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Background: PubMed 16896392Coleman EA, Smith JD, Frank JC, Eilertsen TB, Thiare JN, Kramer AM. Development and testing of a measure designed to assess the quality of care transitions. Int J Integr Care. 2002;2:e02. doi: 10.5334/ijic.60. Epub 2002 Jun 1.
- Results publication: PubMed 12558354Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
- Results publication: PubMed 17054207Mistiaen P, Poot E. Telephone follow-up, initiated by a hospital-based health professional, for postdischarge problems in patients discharged from hospital to home. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD004510. doi: 10.1002/14651858.CD004510.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kheng Hock Lee, MBBS principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a transitional care model in people with Chronic Diseases, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission rate (time frame: 30 days after index discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351648, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.